CMC Regulatory Affairs Manager, Development Biologics

Are you passionate about the application of science to deliver life changing medicines?

Join AstraZeneca, a place built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

We are looking for a Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Manager to join us on a permanent basis in either the US, UK or Sweden.

Our Chemistry, Manufacturing, and Controls (CMC) Regulatory functions span across the product lifecycle and are responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines.
With our expertise we interpret, anticipate and shape global Health Authority expectations to create insightful CMC and Device Regulatory Strategies.

We are the bridge between our R&D functions, Operations sites, Quality and Global Supply Teams in helping safe, effective medicines reach the right patient at the right times. We manage the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products' throughout the commercial lifecycle; including marketing Authoring Applications (MAAs) and all post approval activities maximising the value of business critical Supply Chain changes to the AZ organisation by supplying the regulatory context, intelligence and guidance required to inform the development of robust plans for change initiatives.

What you'll do
As a CMC-RA Manager, you will lead the operational execution of the CMC deliverables in clinical trial applications (CTA) and marketing applications (MA) of biotechnology products and is considered the regulatory CMC module 1 specialist in country-specific regulatory CMC requirements for biologics.

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Accountable for delivering "submission ready" CMC modules to internal and external regulatory partners in compliance with relevant AstraZeneca systems and procedures
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Responsible for updating and communicating agreed submission timelines to CMC-RA leads and CMC and GRET teams
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Works closely with the CMC-RA lead to ensure the agreed submission strategy is executed and to provide complete CTD CMC module 1 documentation per regional regulatory requirements
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Participates in the planning, preparation (including authoring) and delivery of CMC submissions
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Works proactively with Scientific Writing and Scientific Writing Support in the creation and maintenance of Virtual Document in the documentum system
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Collaborates with biologics CMC-RA post-approval team to ensure appropriate transition of CMC dossier
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Partners with appropriate global regulatory functions and external regulatory partners to ensure delivery of CMC files and documentation
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Responsible for lifecycle maintenance of the clinical CMC dossier
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Contributes to monitoring of regulatory CMC environment on regular basis by assessing clinical trial health agency questions database
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Authors and/or reviews CMC-relevant information for clinical trial and marketing applications such as Application Forms, Module 1 Summary of Changes, DSUR, simplified IMPDs and any additional required documentation.
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Develops and builds expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions

Essential for the role

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BS or MS in Scientific field of study
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4+ years of related biopharmaceutical or pharmaceutical industry experience (e.g. analytical development, Quality Control, manufacturing)
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2+ years of Regulatory Affairs CMC submissions experience
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Knowledge of CMC document content and experience with a Documentum based electronic document repository system
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Ability to interpret, understand and effectively communicate relevant FDA, ICH, RoW regulatory CMC requirements relating to electronic submissions
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Knowledge of the drug development process

Date posted: 2021-10-27
Closing Date: 2021-11-24
Compensation & Benefits: Competitive

The role can be based at either of AstraZeneca's vibrant R&D and Production sites in: Gaithersburg (US), Macclesfield (UK), Cambridge (UK), or Södertälje (Sweden)

Why AstraZeneca?
Working on a strong pipeline means so much more than producing innovative, ground-breaking medicines. It allows us to be part of long-term development programs with the variety that comes from working at the leading edge of science and technology.
We explore innovations and confront challenges that others won't, to have a greater impact on patients' lives. We're proud of our pipeline - it's not only changing the face of our industry for good and impacting the lives of patients, it's transforming the careers of our people. We're committed to a culture of continuous learning and people development so everyone at AstraZeneca can grow and thrive.

So, what's next?
Are you already imagining yourself joining us? Good, because we can't wait to hear from you!
Welcome with your application; CV and cover letter, no later than 24th November, 2021.